Saturday, October 30, 2010

On the risks of taking generic drugs and the hypocrisy of tort reformers

Last week, Bloomberg News reported (here) that Dr. Janet Woodcock, head of the Food & Drug Administration’s Center for Drug Evaluation and Research has stated publicly she has ongoing concerns about the level of equivalence between generic drugs and name brand drugs on which the generics are based and about whether generics really meet quality standards. This is a serious concern, which again highlights the deficiencies of the FDA as an oversight agency over an industry that affects - and puts at risk - millions of consumers every day. There are many reports out there of consumers of drugs for depression, epilepsy and other common problems who have complained to the FDA about the negative effects of being switched from brand name drugs to their generic "equivalent." Generic drugs account for the vast majority of all prescriptions in the U.S. so it is imperative to determine if we can trust the FDA to protect our safety. That aside, it is interesting to point out the response to the Bloomberg News story by the Washington Legal Foundation, a think tank that supports, among many other things, tort reform. Here is what they had to say: "Generic drugs account for over 70% of all prescriptions written in the U.S. Scores of branded drugs of increasing complexity are soon to lose their patent protection and become subject to generic competition. It is the ideal time for FDA and its overseers to consider whether FDA’s testing sufficiently protects patient safety. In the least, FDA should responded with more urgency to Dr. Woodcock’s caution this year than it did to her “tide of skepticism” statement in 2009. More must be done than simply publishing informational ads and asking that pharmacies display government posters assuring consumers that FDA is protecting them." You can read the full comment here. Stop the presses!!! The WLF and I agree on something?!! Wow! What is going on at the WLF?! I mean, I would have expected them to argue we should trust the FDA. This would have been consistent with the position that the FDA are the experts and that we should oppose allowing litigation in state courts over defective drugs or inadequate warnings as long as the FDA had approved the drug. So how come they are now saying maybe we should not trust the FDA? Oh... wait. I get it. You see, generics create competition for the name brand manufacturers, so "big pharma" does not want generics on the market. I see.... Federal regulation, and, who knows?, maybe even a little litigation, is OK to make sure generics are safe; but totally out of the question when it comes to questioning the safety of products by the big brand name pharmaceutical companies. Makes total sense now.

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